Phase
Condition
Aplastic Anemia
Anemia
White Cell Disorders
Treatment
Ravulizumab
Ravulizumab OBDS
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female ≥18 years of age
Treated with eculizumab for PNH for at least 3 months prior to Day 1
LDH level ≤1.5 × upper limit of normal (ULN) at screening
PNH diagnosis confirmed by documented high-sensitivity flow cytometry.
Documented meningococcal vaccination not more than 3 years prior to, or at the timeof, initiating study treatment.
Body weight ≥40 to <100 kilogram (kg)
Female participants of childbearing potential must use highly effectivecontraception starting at screening and continuing until at least 8 months after thelast dose of ravulizumab.
Willing and able to give written informed consent and comply with study visitschedule.
Exclusion
Exclusion Criteria:
More than 1 LDH value > 2 × ULN within the 3 months prior to study entry
History of bone marrow transplantation.
History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic diseasethat, in the opinion of the Investigator or Sponsor, would preclude participation.
Unstable medical conditions (for example, myocardial ischemia, activegastrointestinal bleed, severe congestive heart failure, anticipated need for majorsurgery within 6 months of randomization, coexisting chronic anemia unrelated toPNH).
Females who are pregnant, breastfeeding or who have a positive pregnancy test atscreening or Day 1.
Participation in another interventional clinical study or use of any experimentaltherapy within 30 days before initiation of study drug on Day 1 in this study orwithin 5 half-lives of that investigational product, whichever is greater.
Study Design
Study Description
Connect with a study center
Clinical Trial Site
Liverpool,
AustraliaSite Not Available
Research Site
Liverpool, 2170
AustraliaSite Not Available
Clinical Trial Site
Parkville,
AustraliaSite Not Available
Research Site
Parkville, 3050
AustraliaSite Not Available
Clinical Trial Site
Vienna,
AustriaSite Not Available
Research Site
Vienna, 1090
AustriaSite Not Available
Clinical Trial Site
Antwerpen,
BelgiumSite Not Available
Research Site
Antwerpen, 2020
BelgiumSite Not Available
Clinical Trial Site
Brussels,
BelgiumSite Not Available
Research Site
Bruxelles, 1200
BelgiumSite Not Available
Clinical Trial Site
Hasselt,
BelgiumSite Not Available
Research Site
Hasselt, 3500
BelgiumSite Not Available
Clinical Trial Site
Leuven,
BelgiumSite Not Available
Research Site
Leuven, 3000
BelgiumSite Not Available
Clinical Trial Site
Botucatu,
BrazilSite Not Available
Research Site
Botucatu, 18618-970
BrazilSite Not Available
Clinical Trial Site
Ribeirão Preto,
BrazilSite Not Available
Research Site
Ribeirão Preto, 14049-901
BrazilSite Not Available
Research Site
Rio De De Janeiro, 20211030
BrazilSite Not Available
Clinical Trial Site
Rio De Janeiro,
BrazilSite Not Available
Clinical Trial Site
Salvador,
BrazilSite Not Available
Research Site
Salvador, 40170010
BrazilSite Not Available
Research Site
Sao Paulo, 05403-000
BrazilSite Not Available
Clinical Trial Site
São Paulo,
BrazilSite Not Available
Research Site
São Paulo, 01308-050
BrazilSite Not Available
Research Site
Toronto, Ontario M5G 2C4
CanadaSite Not Available
Clinical Trial Site
Toronto,
CanadaSite Not Available
Clinical Trial Site
Helsinki,
FinlandSite Not Available
Research Site
Helsinki, 00029
FinlandSite Not Available
Clinical Trial Site
Amiens,
FranceSite Not Available
Research Site
Amiens, 80054
FranceSite Not Available
Clinical Trial Site
Brest,
FranceSite Not Available
Research Site
Brest, 29609
FranceSite Not Available
Clinical Trial Site
Lille,
FranceSite Not Available
Research Site
Lille, 59037
FranceSite Not Available
Clinical Trial Site
Montpellier,
FranceSite Not Available
Research Site
Montpellier Cedex 5, 34090
FranceSite Not Available
Clinical Trial Site
Nantes,
FranceSite Not Available
Research Site
Nantes cedex 01, 44093
FranceSite Not Available
Clinical Trial Site
Nice,
FranceSite Not Available
Research Site
Nice, 6200
FranceSite Not Available
Clinical Trial Site
Paris,
FranceSite Not Available
Research Site
Paris, 75010
FranceSite Not Available
Clinical Trial Site
Pessac,
FranceSite Not Available
Research Site
Pessac, F-33604
FranceSite Not Available
Research Site
Pierre Benite Cedex, 69495
FranceSite Not Available
Clinical Trial Site
Pierre-Bénite,
FranceSite Not Available
Clinical Trial Site
Poitiers,
FranceSite Not Available
Research Site
Poitiers, 86021
FranceSite Not Available
Clinical Trial Site
Rennes,
FranceSite Not Available
Research Site
Rennes Cedex 9, 35033
FranceSite Not Available
Clinical Trial Site
Strasbourg,
FranceSite Not Available
Research Site
Strasbourg, 67098
FranceSite Not Available
Clinical Trial Site
Tours,
FranceSite Not Available
Research Site
Tours, 37044
FranceSite Not Available
Clinical Trial Site
Catania,
ItalySite Not Available
Research Site
Catania, 95123
ItalySite Not Available
Clinical Trial Site
Milano,
ItalySite Not Available
Research Site
Milano, 20122
ItalySite Not Available
Clinical Trial Site
Roma,
ItalySite Not Available
Research Site
Roma, 00168
ItalySite Not Available
Research Site
Rome, 161
ItalySite Not Available
Clinical Trial Site
Maastricht,
NetherlandsSite Not Available
Research Site
Maastricht, 6229 HX
NetherlandsSite Not Available
Clinical Trial Site
Ekaterinburg,
Russian FederationSite Not Available
Research Site
Ekaterinburg, 620102
Russian FederationSite Not Available
Clinical Trial Site
Moscow,
Russian FederationSite Not Available
Research Site
Moscow, 125284
Russian FederationSite Not Available
Clinical Trial Site
Saint Petersburg,
Russian FederationSite Not Available
Research Site
Saint-Petersburg, 197089
Russian FederationSite Not Available
Research Site
Badalona, 8916
SpainSite Not Available
Clinical Trial Site
Barcelona,
SpainSite Not Available
Research Site
Barcelona, 08036
SpainSite Not Available
Clinical Trial Site
Donostia,
SpainSite Not Available
Research Site
Donostia, 20014
SpainSite Not Available
Clinical Trial Site
Las Palmas De Gran Canaria,
SpainSite Not Available
Research Site
Las Palmas de Gran Canaria, 35020
SpainSite Not Available
Clinical Trial Site
Madrid,
SpainSite Not Available
Research Site
Madrid, 28040
SpainSite Not Available
Clinical Trial Site
Majadahonda,
SpainSite Not Available
Research Site
Majadahonda, 28222
SpainSite Not Available
Clinical Trial Site
Sevilla,
SpainSite Not Available
Research Site
Sevilla, 41013
SpainSite Not Available
Clinical Trial Site
Uppsala,
SwedenSite Not Available
Research Site
Uppsala, 75185
SwedenSite Not Available
Clinical Trial Site
Adana,
TurkeySite Not Available
Research Site
Adana, 01330
TurkeySite Not Available
Research Site
Istambul, 34899
TurkeySite Not Available
Clinical Trial Site
Istanbul,
TurkeySite Not Available
Research Site
Istanbul, 34096
TurkeySite Not Available
Research Site
Izmir, 35100
TurkeySite Not Available
Research Site
İstanbul, 34093
TurkeySite Not Available
Clinical Trial Site
İzmir,
TurkeySite Not Available
Clinical Trial Site
Los Angeles, California 90033
United StatesSite Not Available
Research Site
Los Angeles, California 90089
United StatesSite Not Available

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